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Bone Mass Accrual in Adolescent Athletes (838)

Primary Purpose

Amenorrhea, Bone Loss

Status
Withdrawn
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Estrogen
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Amenorrhea focused on measuring amenorrhea, athletes, bone loss, eumenorrhea

Eligibility Criteria

18 Years - 21 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Female
  • 18-21 years of age
  • Hypothalamic amenorrhea
  • Greater than or equal to 15 years bone age
  • BMI between 10th-90th percentiles for age

Exclusion Criteria:

  • Use of medications affecting bone metabolism including estrogen/ progesterone, anabolic steroids and glucocorticoids except local application of glucocorticoid creams (washout period of three months necessary prior to study enrollment if medically permissible to discontinue these)
  • Presence of anorexia nervosa or %IBW of < 85% based on the 50th %ile of BMI for age
  • Spine BMD Z-score < -3
  • Conditions other than endurance training that may cause amenorrhea including PCOS (clinical or preceding laboratory evidence of hyperandrogenism with amenorrhea)
  • Conditions other than endurance training that may cause bone metabolism to be affected
  • Abnormal TSH, elevated FSH, hematocrit < 30%
  • Pregnancy

For girls with AA (to be randomized to estrogen and progesterone or no treatment)

  • History of migraines, hypertension, allergy to peanut oil, undiagnosed abnormal genital bleeding, known, suspected or history of breast or genital cancer or estrogen dependent neoplasia, known hypersensitivity to progesterone or estrogen or other product ingredients, liver dysfunction or disease
  • LFTs greater than 1.5 times the upper limit of normal

  • Family history or personal history of conditions that may increase risk of thromboembolism:

    1. Family history of myocardial infarction or strokes occurring at less than 50 years
    2. Family history of clotting disorders: normal coagulation profile will be necessary for enrollment
  • History of smoking >10 cigarettes a day (history of smoking >14 cigarettes a day is a contraindication for estrogen, but we will be more conservative in our exclusion criteria)
  • Personal history of blood clots

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Estrogen and lifestyle

Lifestyle

Arm Description

Outcomes

Primary Outcome Measures

Bone density

Secondary Outcome Measures

Full Information

First Posted
January 16, 2009
Last Updated
October 22, 2021
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00827151
Brief Title
Bone Mass Accrual in Adolescent Athletes
Acronym
838
Official Title
"2008P-00346: Bone Mass Accrual in Adolescent Athletes"
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Withdrawn
Why Stopped
The study was not funded
Study Start Date
December 2008 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
January 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The adolescent and young adult years are a critical window in time for bone mineral accrual. More than 90% of peak bone mass is achieved by 18 years, and data indicate that insults sustained during adolescence and young adulthood may result in permanent deficits in bone accrual. Adult athletes with amenorrhea (AA) have low bone mineral density (BMD) secondary to hypogonadism, associated with increased fracture risk and associated co-morbidities. We will examine whether estrogen replacement will increase BMD and improve measures of bone microarchitecture in adolescents and young women with AA, thus optimizing peak bone mass.
Detailed Description
Young female athletes 18-21 years old will be randomized to estrogen (and progesterone) with lifestyle modification versus lifestyle modification alone for a 12 month period. Bone density and structure will be assessed over this period. Hormonal evaluations will also be performed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amenorrhea, Bone Loss
Keywords
amenorrhea, athletes, bone loss, eumenorrhea

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Estrogen and lifestyle
Arm Type
Active Comparator
Arm Title
Lifestyle
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Estrogen
Other Intervention Name(s)
Vivelle-Dot, Prometrium
Intervention Description
Estrogen 100 mcg patch twice weekly with 10 days of oral progesterone monthly for 12 months versus no medication
Primary Outcome Measure Information:
Title
Bone density
Time Frame
One year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Female 18-21 years of age Hypothalamic amenorrhea Greater than or equal to 15 years bone age BMI between 10th-90th percentiles for age Exclusion Criteria: Use of medications affecting bone metabolism including estrogen/ progesterone, anabolic steroids and glucocorticoids except local application of glucocorticoid creams (washout period of three months necessary prior to study enrollment if medically permissible to discontinue these) Presence of anorexia nervosa or %IBW of < 85% based on the 50th %ile of BMI for age Spine BMD Z-score < -3 Conditions other than endurance training that may cause amenorrhea including PCOS (clinical or preceding laboratory evidence of hyperandrogenism with amenorrhea) Conditions other than endurance training that may cause bone metabolism to be affected Abnormal TSH, elevated FSH, hematocrit < 30% Pregnancy For girls with AA (to be randomized to estrogen and progesterone or no treatment) History of migraines, hypertension, allergy to peanut oil, undiagnosed abnormal genital bleeding, known, suspected or history of breast or genital cancer or estrogen dependent neoplasia, known hypersensitivity to progesterone or estrogen or other product ingredients, liver dysfunction or disease LFTs greater than 1.5 times the upper limit of normal Family history or personal history of conditions that may increase risk of thromboembolism: Family history of myocardial infarction or strokes occurring at less than 50 years Family history of clotting disorders: normal coagulation profile will be necessary for enrollment History of smoking >10 cigarettes a day (history of smoking >14 cigarettes a day is a contraindication for estrogen, but we will be more conservative in our exclusion criteria) Personal history of blood clots
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Madhu Misra, MD, MPH
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

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Bone Mass Accrual in Adolescent Athletes

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